FDA SOLICITS PUBLIC COMMENT ON SEVERAL DRUGS, INCLUDING PREGABALIN, TRAMADOL, CBD AND OTHERS

Do you use pregabalin (Lyrica), tramadol (Ultram), cannabidiol (CBD) or ketamine (Ketalar)? If so, the U.S. Food and Drug Administration (FDA) is seeking your comments on the “abuse potential, actual abuse, medical usefulness, trafficking and impact of scheduling changes on availability for medical use” of these drugs and several others, according to the Federal Register.

The request comes after the World Health Organization (WHO) notified the FDA that it is considering international restrictions on these drugs. Submitted comments will be considered by the U.S. Department of Health and Human Services (HHS) as it prepares an evaluation of each drug for WHO.

The HHS evaluations will not include recommendations on whether these drugs should be subjected to international controls. “Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in early 2018,” reads the Federal Register notice. “Any HHS position regarding international control of these drug substances will be preceded by another Federal Register notice soliciting comments,” as required by federal law.

Feedback is being requested for the following drugs:

Pregabalin (Lyrica), an anticonvulsant drug that’s used to treat fibromyalgia, diabetic peripheral neuropathy, post-herpetic neuralgia and epilepsy. There have been reports, especially in the United Kingdom, that some people are taking high doses of pregabalin to achieve euphoria.

Tramadol (Ultram), a synthetic opioid that’s commonly prescribed for moderate to moderately-severe pain. It is a schedule IV controlled substance in the U.S.

Cannabidiol (CBD), one of the active cannabinoids in cannabis. Unlike THC, the most well-known ingredient in cannabis, CBD does not cause a euphoric high. It has been shown to be helpful in the treatment of epilepsy, nerve pain and other conditions. Several cannabis-based CBD products are currently being studied in clinical trials in the U.S. CBD from the cannabis plant is listed as a schedule I controlled substance in the U.S.

Ketamine, a general anesthetic that’s used for short diagnostic and surgical procedures. Some private clinics are now offering ketamine infusions for chronic pain.

Ocfentanil, a synthetic opioid that’s similar to fentanyl. It has no approved medical use in the U.S.

Furanylfentanyl (Fu-F), a clandestinely produced synthetic opioid that’s similar to fentanyl. It’s commonly abused and connected with fatal overdoses. It has no approved medical use in the U.S.

Acryloylfentanyl (acrylfentanyl), another clandestinely produced synthetic opioid that’s similar to fentanyl. It’s sold illegally on some websites and is known to have addictive properties. It is not approved for any medical use in the U.S.

Carfentanil (4-carbomethoxyfentanyl), a synthetic opioid that’s approximately 100 times more potent than fentanyl. It is approved by the FDA for limited use among veterinarians for immobilizing large animals. It is not approved for human use, but is commonly laced with heroin and sold illegally in the U.S.

4-Fluoroisobutyrfentanyl, a clandestinely produced synthetic opioid that’s similar to fentanyl. It has been implicated in several fatal overdoses, and is not approved for any medical use in the U.S.

Tetrahydrofuranylfentanyl (THF-F), a synthetic opioid that’s similar to fentanyl. It is not approved for any medical use in the U.S.

4-Fluoroamphetamine (4-FA), a psychoactive substance of the phenethylamine and substituted amphetamine chemical classes. It produces stimulant effects and has been linked to fatal overdoses. It is not approved for any medical use in the U.S.

AB-PINACA, a clandestinely produced synthetic cannabinoid agonist that’s approximately 1.5 times more potent than THC, the active ingredient in cannabis. It has contributed to cases of overdose. It is not approved for any medical use in the U.S.

AB-CHMINACA, a clandestinely produced synthetic cannabinoid agonist that is approximately 16 times more potent than THC. It has contributed to cases of overdose and can cause death.

5F-PB-22, a synthetic cannabinoid agonist with effects similar to THC. It is used as an ingredient in herbal products and is smoked for its psychoactive effects. It has been linked to fatal overdoses, and is a schedule I controlled substance in the U.S.

UR-144, a clandestinely produced synthetic cannabinoid agonist. It has been detected in herbal smoking blends sold as incense, and is a schedule I controlled substance in the U.S.

5F-ADB, a clandestinely produced synthetic cannabinoid agonist. It has been temporarily listed as a schedule I controlled substance in the U.S.

Etizolam (Etilaam, Etizest and others), a benzodiazepine, which depresses the central nervous system, and is used as a treatment in some countries for insomnia, anxiety and seizure disorders. It is not approved for medical use in the U.S.

WHO’s Expert Committee on Drug Dependence will meet in November to review these substances for potential “dependence, abuse and harm to health, and will make recommendations to the United Nations secretary-general on the need for and level of international control of these substances.